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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device calibrator, multi-analyte mixture
Product CodeJIX
Regulation Number 862.1150
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER IRELAND INC
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTICA STAGO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELITECHGROUP
  SUBSTANTIALLY EQUIVALENT 3
GENCHEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICA CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 7
SIEMENS HEALTHCARE DIAGNOSTICS INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VERICHEM LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
VITAL DIAGNOSTICS (MANUFACTURING) PTY LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 35 35
2015 4 4
2016 6 6
2017 17 17
2018 16 16
2019 12 12
2020 22 22
2021 9 9
2022 11 11
2023 13 13
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
High Test Results 94 94
Low Test Results 32 32
Nonstandard Device 18 18
Incorrect, Inadequate or Imprecise Result or Readings 10 10
Calibration Problem 8 8
Incorrect Or Inadequate Test Results 6 6
Adverse Event Without Identified Device or Use Problem 4 4
High Readings 4 4
Defective Component 2 2
False Reading From Device Non-Compliance 2 2
Non Reproducible Results 2 2
Device Handling Problem 1 1
Material Split, Cut or Torn 1 1
Device Sensing Problem 1 1
Mechanical Problem 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 72 72
No Clinical Signs, Symptoms or Conditions 45 45
No Consequences Or Impact To Patient 28 28
Laceration(s) 3 3
Hyperglycemia 1 1
Test Result 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AMS Diagnostics, LLC III Jul-13-2017
2 Abbott Laboratories Inc. II Jun-25-2015
3 Abbott Laboratories Inc. II Feb-06-2009
4 Abbott Laboratories Inc. II Jan-12-2009
5 Beckman Coulter Inc II Jul-13-2017
6 Beckman Coulter Inc. II Feb-13-2018
7 Beckman Coulter Inc. III Oct-22-2012
8 Cargille-Sacher Laboratories Inc. III Dec-01-2009
9 Chromsystems Instruments & Chemicals GmbH II Dec-04-2020
10 Chromsystems Instruments & Chemicals GmbH II Dec-02-2020
11 ELITech Clinical Systems SAS II Aug-01-2018
12 Horiba Instruments, Inc dba Horiba Medical II Mar-05-2014
13 Kamiya Biomedical Company, LLC II Oct-20-2017
14 Ortho Clinical Diagnostics II Aug-06-2019
15 Ortho Clinical Diagnostics Inc II Feb-13-2020
16 Ortho-Clinical Diagnostics III Sep-14-2018
17 Ortho-Clinical Diagnostics II Aug-13-2014
18 Ortho-Clinical Diagnostics II Feb-25-2014
19 Ortho-Clinical Diagnostics III May-17-2013
20 Ortho-Clinical Diagnostics II Mar-22-2012
21 Ortho-Clinical Diagnostics II Jan-27-2012
22 Ortho-Clinical Diagnostics, Inc. II Mar-23-2021
23 Randox Laboratories Ltd. II Mar-20-2024
24 Randox Laboratories Ltd. II Jan-18-2024
25 Randox Laboratories Ltd. II Jan-18-2024
26 Randox Laboratories Ltd. II Jan-18-2024
27 Randox Laboratories Ltd. II Aug-23-2023
28 Randox Laboratories Ltd. II May-12-2021
29 Randox Laboratories Ltd. II Nov-04-2019
30 Randox Laboratories Ltd. III Sep-07-2019
31 Randox Laboratories Ltd. II Dec-21-2018
32 Roche Diagnostics Corp. II Jan-06-2009
33 Siemens Healthcare Diagnostics II Sep-15-2014
34 Siemens Healthcare Diagnostics Inc II Dec-21-2023
35 Siemens Healthcare Diagnostics, Inc II Mar-08-2016
36 Siemens Healthcare Diagnostics, Inc II Dec-16-2014
37 Siemens Healthcare Diagnostics, Inc. II Feb-18-2020
38 Siemens Healthcare Diagnostics, Inc. II Mar-26-2018
39 Siemens Healthcare Diagnostics, Inc. III Feb-16-2017
40 Siemens Healthcare Diagnostics, Inc. II Nov-22-2016
41 Siemens Healthcare Diagnostics, Inc. II Mar-25-2015
42 Siemens Healthcare Diagnostics, Inc. II Sep-30-2014
43 Siemens Healthcare Diagnostics, Inc. II Feb-24-2014
44 Siemens Healthcare Diagnostics, Inc. III Sep-09-2010
45 Siemens Healthcare Diagnostics, Inc. II May-04-2010
46 Siemens Healthcare Diagnostics, Inc. II Feb-26-2010
47 Tosoh Bioscience Inc III Aug-15-2018
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